The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Ventanna Anti-cd3 Primary Antibody.
| Device ID | K941505 |
| 510k Number | K941505 |
| Device Name: | VENTANNA ANTI-CD3 PRIMARY ANTIBODY |
| Classification | Lambda, Antigen, Antiserum, Control |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. 3865 N. BUSINESS CENTER DR. Tucson, AZ 85705 |
| Contact | Stephen A Tillson |
| Correspondent | Stephen A Tillson VENTANA MEDICAL SYSTEMS, INC. 3865 N. BUSINESS CENTER DR. Tucson, AZ 85705 |
| Product Code | DEH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-29 |
| Decision Date | 1996-05-30 |
| Summary: | summary |